Description

Summary

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma. Phase 2 of this study will consist of 4 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Official Title

A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Details

This study will be conducted in two parts.

Phase 1b is dose escalation in which patients are tested with SD-101 at various doses in combination with 200 mg pembrolizumab in patients with metastatic melanoma.

Phase 2 will consist of 4 expansion cohorts to evaluate the efficacy and safety of SD-101 given in combination with 200 mg pembrolizumab in specific melanoma populations and recurrent or metastatic HNSCC.

At least 2 sites of measurable disease of which 1 must be palpable or visualized by ultrasound and easily accessible to multiple intratumoral injections. The injected lesions must qualify as a measurable target lesion per RECIST 1.1.

Metastatic melanoma patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy must have documented PD per RECIST 1.1 while receiving a prior anti-PD-1/L1 therapy and must have received a prior anti-PD-1/L1 agent within 12 weeks of study enrollment.

Inclusion Criteria: Phase 2 HNSCC patients

Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not be treated with curative intent.

Have at least 1 measurable site of disease (target lesion per RECIST 1.1, which must be accessible and amenable to multiple intratumoral injections. If superficial, the lesion must measure at least 10 mm in diameter, measured by calipers, and be documented photographically.

Recurrent or metastatic HNSCC patients with PD while receiving anti-PD-1/L1 therapy must have documented PD per RECIST 1.1 while receiving anti-PD-1/L1 therapy and must have received anti-PD-1/L1 agent within 12 weeks of study enrollment.

You CAN'T join if...

Received small molecule inhibitor targeted therapy, such as tyrosine kinase inhibitors, within 2 weeks prior to study enrollment.

Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy (including immune modulators or systemic corticosteroids) within 7 days prior to study enrollment

Is expected to require any other form of anti-cancer therapy while in the trial.